Would you eat genetically-engineered salmon?

Susan Dudley

Susan E. Dudley is Director of the George Washington University Regulatory Studies Center, which works to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She formerly served as Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget.

The Food and Drug Administration’s public meetings last week on what may be the first genetically-engineered (GE) animal marketed for human consumption have stimulated a lot of discussion. People differ on whether the sale of AquAdvantage Salmon — which, due to the addition of a gene from the Chinook salmon, grows to full-size in less than half the time of its non-engineered Atlantic salmon cousins — will be a boon or a bane.

Would you eat this GE salmon? I would. There need not be any conflict here, though, as grocery stores are filled with foods that some people like and others shun. Why not allow people the freedom to make the decision for themselves? To answer this question, it’s important to understand how the FDA regulates products of biotechnology.

The majority of our food supply (the exception being food harvested in the wild) has been genetically modified over the years through selective breeding and other traditional methods. Recent concerns over “genetic engineering” relate to the newer techniques using recombinant DNA (rDNA). Many scientists find these concerns unfounded, because the new biotechnology techniques are more precise and reliable than traditional, trial-and-error techniques. For years the stated US policy has been to focus regulation on the characteristics of the product of genetic engineering, rather than the particular method used to achieve it. Following this philosophy, rDNA techniques have been applied successfully to key food crops, so that today over 70 percent of the corn and 90 percent of the soybeans grown in America are genetically engineered. To date, however, the U.S. government has never approved a GE animal for human consumption.

In January 2009, in a move that many saw as contrary to the long-standing policy of regulating based on the risks of the product, rather than the method, the FDA announced that it would regulate GE animals as if they were new animal drugs, requiring pre-marketing approval from FDA’s Center for Veterinary Medicine (CVM). The new animal drug approval process requires the manufacturer to provide the FDA with extensive data demonstrating both the “safety” and the “efficacy” of the product. In the case of the salmon, which AquaBounty has been developing for about 15 years, CVM’s preliminary determination is that it is “safe” for human consumption (because the salmon is indistinguishable from other Atlantic salmon) and the environment (the AquAdvantage salmon do not risk interbreeding with wild salmon because they are all sterile females and will be raised in land-based tanks). Indeed, it appears that the GE salmon will be better for the environment than either wild-caught salmon (which suffer from overfishing) or traditionally-farmed salmon (which may pose environmental risks). CVM has also determined the salmon is “effective” in that they really do grow faster.

If, as expected, FDA’s CVM does approve the GE salmon, a separate arm of FDA — its Center for Food Safety and Applied Nutrition (CFSAN) — will make a decision as to whether and how it should be labeled. Under FDA’s food labeling rules, the agency cannot require the salmon to carry a separate label unless it is materially different from non-engineered salmon (which it appears not to be). That makes sense to me, but here’s the rub: FDA rules may also not allow producers to inform consumers about whether the Atlantic salmon they’re purchasing involved the spliced Chinook gene. This is because FDA is not only concerned that labels be truthful, but that they not mislead consumers. In deciding whether firms selling conventional Atlantic salmon can label their products as not genetically engineered, the FDA will not only consider whether such claims can be supported (e.g., through tracing or testing) but also whether such a claim might falsely imply that the non-GE salmon is safer.

Generally, though, your false assumption about cancer rates fits in nicely with the rest of your letter. You apparently think you know something because you’ve heard it somewhere, and you can’t be bothered to find out whether or not its credible. But just because a friend told you something, or you saw it on TV, or read it on some website, doesn’t make it true.

The fact of the matter is, unless you’re eating only wild game and fish, wild nuts and berries, and wild herbs, nothing in your diet consists of “what the earth [has given] us.” Every animal and plant grown on a farm has been modified at the genetic level by human hands over thousands of years. And most of these modifications have been far more invasive and unpredictable than the modern techniques of recombinant DNA.

That’s a good thing, as it turns out, since the wild progenitors of nearly every plant that we now customarily eat contain high levels of potent toxins. Potatoes and tomatoes, for example, are in the same taxonomic class as poisonous nightshade, and wild varieties of those plants are toxic enough to kill humans. In order to make the fruits and vegetables in the modern human diet safe enough to eat, farmers and plant breeders have had to use a number of crude techniques to alter the genetic code of the plants.

Indeed, most of the fruits and vegetables that humans now eat have at least one relative that was bred with what’s known as mutation breeding. They’ve been zapped by x-rays or some other form of ionizing radiation, or doused with mutagenic chemicals, in order to generate random genetic mutations with the hope that some of those mutations would prove agronomically useful. See, for example, this material (http://mvgs.iaea.org/) from the International Atomic Energy Agency for a description of the process and a list of a few of the more prominent mutant varieties.

Compared to mutation breeding and many of the other forms of “conventional” plant and animal modification, recombinant DNA is remarkably more precise and predictable, as dozens of scientific societies all around the world have concluded time and again. Indeed, compared with the thousands of more or less random, and wholly uncharacterized genetic alterations that are part and parcel of the conventional plant breeder’s toolbox, the addition or deletion of just one or two genes using rDNA techniques is vastly more safe.

When modifying the AquaBounty salmon, the breeders chose two well-known and fully characterized genetic sequences. One of these, the gene encoding a growth hormone protein from Pacific Chinook salmon, is functionally identical to the endogenous growth hormone gene already in every single wild Atlantic salmon, and it performs exactly the same role. The other gene sequence is a promoter that merely tells the growth hormone gene not to stop making the growth hormone protein when the water temperature falls in the winter time. That’s how the AquaBounty salmon reaches full market weight in half the time as conventional farmed salmon. And the genes are inserted into the Atlantic salmon DNA in a way that doesn’t disturb the normal functioning of the animal’s endogenous genes — something that rarely can be said for conventional plant and animal breeding.

Of course, we cannot know with metaphysical certainty what the long-term effects of the modification will be. But because we know exactly what genetic modifications were made, and we know that they consist merely of the addition of genetic sequences that generate the production of a protein that’s safe for human consumption, we have a heck of lot more predictive ability when it comes to the AquaBounty salmon (or any other rDNA-engineered animal or plant, for that matter) than we do with any other breeding method.

Naturally, you and every other consumer are entitled to vote with your dollars and eat whatever some producer is willing to sell to you. But please don’t carry on under the delusion that what you’re eating — from a small farm or large, local or foreign, organic or conventional — is in any way, shape or form “what the earth has given us.”

regcheck

Desiree,

You are certainly correct that safety studies are not done in humans. Human studies are considered unethical. Some government agencies (though I don’t know if the FDA is one) would refuse to accept data obtained from a human study, no matter how carefully it was performed. So there’s really nothing that can be done to answer your question directly.

Incidentally, human testing is not done for anything except prescription drugs. So both Aquabounty and the FDA are in a conundrum: How should they go about proving safety? Is there any evidence that you’d consider sufficient? If not, then you should happily admit that science doesn’t matter to you, that your opinion is grounded only in ideology, and that imposing your ideology on everyone else is your paramount goal.

BTW, about those free range chickens you like so much: They are genetically engineered, too, through old-fashioned selective breeding. Who tested them to make sure they are safe over a lifetime of consumption?

Desiree

Dearest Regcheck (if thats your real name),

my chickens are heirloom variety pastured chickens that I get from my mom’s neighbor so they are not exactly the normal “free rangers” Although I do know what your talking about and who knows. It seems to me if the chickens aren’t cooped up 8 to a cage and having their legs buckle underneath their too fastly growing bodies than that is a good thing, right? And science DOES matter to me. I want more than anything to see with proof from science some of the things that I can only (for now) know in my gut. You have admitted that the science just isn’t there because of this conundrum between the FDA and Aquabounty and other companies that develope such products. The science that I would consider to be valid would NOT be science from Aquabounty. Thats for darn sure. If were not going to do careful studies on humans before unleashing products onto the American people than I guess we’re all the guinea pigs!

What IS happening in this country over the last 30 or 40 years is obesity, high blood pressure, cancer, heart disease and a host of other diseases that YES existed a hundred years ago but not like today. Its very apparent to me that there is a connection between the way we eat, what we eat and how healthy we are. (thanks for those cancer charts greg~ nice touch!)

As far as an ideology is concerned, yes this is the way I look at the world. It’s not political, it’s about humans, animals, plants and the earth. I want to be conscious of the what I put in my body and what I leave behind for my kids. We MUST have these conversations to better ourselves as people. Not only to open my own mind but try to open yours as well.

As far as you GregC, You know alot about mutations and recombinant DNA and thats just dandy. I’m fully aware that our food has evolved and also been purposefully changed in ways by humans all along our history. I think that your just trying to “poke fun at the hippie” by condescending to me about my “what the earth has given us” comment. Just because I want to eat food as simply as possible doesn’t make me some dirt sucking hippie. I like the way it tastes. I like the way I feel when I eat that way. Maybe you should try it.

D

regcheck

Desiree,

I appreciate the time you have taken to respond and I welcome the civil dialogue. BTW, “Regcheck” is the user name I selected when I signed up, but you can find some of my work at http://www.neutralsource.org, where my real name is posted. Also BTW, I do not work, directly or indirectly, for Aquabounty.

Regarding the science, I accept that you now recognize the difficulty of establishing “proof” of safety; that you are not sure what evidence would satisfy you; and that it is possible there is no evidence would be sufficient. I encourage you to think hard about reflexively distrusting the science that Aquabounty has funded. A fundamental element of the Precautionary Principle establishes the burden of proof of safety on Aquabounty, and FDA rules prescribe in great detail what that proof must look like. So, if you reject all science that Aquabounty pays for, and you do so just because they paid for it, then you are denying them any ability at all to satisfy the burden of proof imposed on them under the Precautionary Principle and FDA regulations. That would mean the Precautionary Principle is a ruse and a sham, not a principle at all.

Regarding the policy decision FDA must make, an analogous argument holds. If Aquabounty meets the burden of proof established by the FDA, but the FDA decides to reject its product anyway, then the FDA rules are a ruse and a sham, not a legitimate way to make public decisions. Government agencies cannot legitimately establish rules and procedures, but ignore them if they don’t like the outcome.

Few would dispute your right to choose what you eat or feed to your family. What many reasonably dispute is whether you ought to have the right to deny others the same right. Yet, that is a claim you made in your initial post. Are you sure you really mean that? If so, what possible justification do you have for claiming this authority?

Desiree

I just want to say that while you are OK with eating genetically engineered corn, soy, tomatos, and now (hopefully not) fish, I for one say NO, NO, NO! First of all we don’t know the long term effects of consuming GMO’s. Why? They don’t do studies on humans. How can the FDA even think of approving substances (food or otherwise) that we don’t have all the facts on? They DO do tests on lab rats however and when lab rats are fed a steady diet of GMO’s they end up with stomach lesions, low birth weights and higher instances of cancer. I’m not saying this is the reason why cancer has gone through the roof in this country but I’M SURE IT DOESN’T HELP!

All we can do anymore is vote with our dollars. Thats why I buy my beef and chicken from local farms, eggs too, and produce whenever I can. It is a FACT that factory farming is rampant with disease and inhumane practices. Small farms are the only way to insure safe food. KNOW WHERE YOUR FOOD COMES FROM AND LIVE WELL!

I’ve lost all faith in the FDA. Every time they approve a drug, 10 years later it starts killing people and they remove it. OVER AND OVER this happens. People need to wake up and realize that these things don’t kill you over night. It can take 10 20 or 30 years for the impact of an unnatural diet come to be fully recognized.

My final thought on the FDA is that they are totally in bed with all these other corporations that make it completely biased and ineffective! It all comes down to the all mighty dollar. There is no way Aquabounty would spend the last 15 years developing this abomination if they weren’t certain that the FDA would approve it. Something is fishy here and IT STINKS!

I hope and pray that the FDA does NOT approve it, although the author of this lack-luster article seems to think they will, so WHO KNOWS?

To the people that read this I hope that you take a moment today to think about what you eat and where it came from. Were the fruits created in a lab, or grown from the ground as nature intended? Did the chicken sandwich you ate for lunch come from a healthy chicken that ate grass, worms, seeds, etc and get lots of sunshine? Likely NOT. More than likely it never saw the sun a day in it’s life and was fed a diet of god only know what (chicken parts, feces, etc). If we think producing our food supply in this manner is safe, we most certainly will continue to be a very sick nation.

DOWN WITH GMO’s AND UP WITH WHAT THE EARTH GIVES US, UNADULTERATED WHOLESOME FOOD:):):)